Annual Follow-up Clinical Trial
— Follow-upOfficial title:
Evaluation of a New Long-term Total Articular Prosthesis Follow-up Strategy by Simple Questionnaire and Radiography
| Verified date | April 2020 |
| Source | University Hospital, Clermont-Ferrand |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
Ever-evolving prosthetic activity as described in a Swedish study that predicts 469 TKA per
10,000 inhabitants in 2130. Increased consultation of controls and post-arthroplasty
follow-up is expected. There is a legal obligation to ensure long-term follow-up without
official recommendation on follow-up procedures. The objective is to compare a consultation +
Xray by the surgeon versus an Xray and a questionnaire completed by the patient who had a
knee or hip replacement. This is to demonstrate the equivalence of both.
All patients who come back for an annual check of a prosthesis should complete this
questionnaire and perform an X-ray of their prosthesis. The study lasts one year and includes
all the patients with a previous knee or hip arthroplasty.
The result of the questionnaire and Xray will be compared to that of the consultation and
Xray.
| Status | Completed |
| Enrollment | 656 |
| Est. completion date | October 30, 2019 |
| Est. primary completion date | October 30, 2019 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Patients who have had a primary total hip or total knee arthroplasty that must be seen again in 2017. Normally at 3 months, 1 years, 3, 5, 10, 15 and 20 years post-operatively Exclusion Criteria: - Patients who have previous complications with their joint replacement |
| Country | Name | City | State |
|---|---|---|---|
| France | Chu Clermont-Ferrand | Clermont-Ferrand |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital, Clermont-Ferrand |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Patients seen in consultation follow-up or not (yes / no). | Feasibility study of a new strategy of follow-up by questionnaire | at 3 months | |
| Primary | Patients seen in consultation follow-up or not (yes / no). | Feasibility study of a new strategy of follow-up by questionnaire | at 1year | |
| Primary | Patients seen in consultation follow-up or not (yes / no). | Feasibility study of a new strategy of follow-up by questionnaire | at 3 years | |
| Primary | Patients seen in consultation follow-up or not (yes / no). | Feasibility study of a new strategy of follow-up by questionnaire | at 5 years | |
| Primary | Patients seen in consultation follow-up or not (yes / no). | Feasibility study of a new strategy of follow-up by questionnaire | at 10 years | |
| Primary | Patients seen in consultation follow-up or not (yes / no). | Feasibility study of a new strategy of follow-up by questionnaire | at 15 years | |
| Primary | Patients seen in consultation follow-up or not (yes / no). | Feasibility study of a new strategy of follow-up by questionnaire | at 20 years | |
| Secondary | economic impact (Number of working day) | Number of working day in days | at 3 months, 1, 3, 5, 10, 15 and 20 years post-operatively. | |
| Secondary | economic impact (Number of consultations) | Number of consultations with the surgeon, | at 3 months, 1, 3, 5, 10, 15 and 20 years post-operatively. | |
| Secondary | economic impact (Number of radiography) | Number of radiography realized by the patient | at 3 months, 1, 3, 5, 10, 15 and 20 years post-operatively. | |
| Secondary | economic impact (Cost phone call) | According to the number of realized phone call | at 3 months, 1, 3, 5, 10, 15 and 20 years post-operatively. | |
| Secondary | Evaluation of the feasibility of the questionnaire for detection of certain complications | Evaluation of the feasibility of the questionnaire method | at 3 months, 1, 3, 5, 10, 15 and 20 years post-operatively. |